Botulinum Toxin Testing

The use of natural products as novel therapeutics in medical and cosmetic indications has increased in recent years. Of specific interest is botulinum toxin produced by the bacterium Clostridium botulinum that is known to induce localized flaccid paralysis. The ability to induce and control flaccid paralysis has demonstrated to be of clinical value in the treatment of muscle spasms, chronic pain, migraine headaches, hyperactive nerves, and eye muscle disorders among others. While botulinum toxin is generally considered safe in a clinical setting, its development and use are highly regulated by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) given its potent and potentially harmful biological mechanism of action. Pacific BioLabs works closely with both federal agencies to ensure compliance with regulations associated with the safe handling of botulinum toxin.

Since 1990, Pacific BioLabs has been offering an in vivo potency assay that determines the activity of a botulinum toxin pharmaceutical ingredient (e.g., Drug Substance) or the final formulated drug product as a component of the supply chain for commercial Clients. Pacific BioLabs also offers both in vivo and in vitro test services for the detection of antibodies to botulinum toxin that, if present, have the potential to render botulinum toxin therapeutics less effective.

Botulinum Toxin Bioassay – In Vivo Potency Lot Release Assay

Each therapeutic preparation of botulinum toxin is required by the FDA to be tested for potency and stability before being released for use.  A potency test ensure that all domains of the botulinum toxin protein are functional and that the biological activity of the entire molecule is within specifications. Pacific BioLabs supports testing of both the active pharmaceutical ingredient (Drug Substance) and the final formulated product (Drug Product) for potency and stability.

BoNT In Vivo Mouse Protection Assay – Patient Serum Testing

Patients undergoing treatment with botulinum toxin may develop antibodies that make the toxin ineffective, or less effective, against the indication for which they are being treated. Therefore, during clinical trials it may be important to determine if antibodies against the toxin are neutralizing the drug. Patient serum samples can be submitted by companies conducting a clinical trial to Pacific BioLabs for testing in an in vivo assay that will confirm the presence or absence of neutralizing antibodies to botulinum toxin.  The botulinum toxin mouse protection assay may be used to support developmental activities, including ongoing clinical trials, and post market clinical surveillance programs.

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